Director, Analytical Sciences

MacroGenics is seeking a Director, Analytical Sciences to lead the development, qualification, and transfer of robust analytical methods for complex biological molecules. The role will oversee early-phase and late-phase method development, qualification, transfer to QC, and establish specifications for clinical & commercial products.

Requirements

• Manage a team of scientists and associates on developing and qualifying robust analytical methods
• Provide technical and strategic leadership on developing analytical methods for release and characterization of Drug Substance and Drug Product
• Oversee transfer of analytical methods to Quality Control or contract test labs
• Lead and coordinate with CMC and regulatory teams to establish specifications for release and stability of Drug Substance and Drug Product
• Author and review technical reports, regulatory dossiers, and address questions from Health Authorities

Benefits

• Medical / dental / vision / prescription coverage
• Employee wellness resources
• 401(k) plan with employer match
• Access to an Employee Stock Purchase Plan (ESPP)
• Paid time off & paid parental leave benefits
• Disability benefits